The U.K. Medicines and Healthcare Products Regulatory Agency just released a new device-specific vigilance guidance document on software as a medical device. Sponsors will likely be most interested in the provided examples of the types of events that could be reportable and what the agency expects.
Background on medical device vigilance in the U.K. – Regulation and guidance
The U.K. is currently operating under its national version of the European medical device and IVD directives (MDD, AIMDD and IVDD, respectively).
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